Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761040
Company: WYETH PHARMS INC

Products on BLA 761040

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BESPONSA	INOTUZUMAB OZOGAMICIN	0.9/MG/VIAL	POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761040

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2017	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761040Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761040Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2024	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761040s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761040Orig1s003ltr.pdf

Labels for BLA 761040

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2024	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761040s003lbl.pdf
03/06/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761040s003lbl.pdf
08/17/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf